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India’s health ministry is proposing to spend more than $280 million to strengthen the country’s national and state drug regulatory systems, with the aim of speeding approval decisions and testing of products. Read More
Canadian regulators will have sweeping new powers to order drug recalls, require labeling changes and postmarket studies, and release confidential business information under a rewrite of the country’s drug safety law. Read More
The House late last night approved nearly $1.7 billion in funding for FDA’s drug and biologics activities next year, a slight boost from current levels. Read More
The European Medicines Agency is lending support to an initiative to qualify biomarkers that can provide early warning of an investigational compound’s risks of causing drug-induced kidney injuries. Read More
The EU ombudsman is questioning the European Medicines Agency’s claim that it wasn’t violating any laws when it allowed AbbVie to redact information from clinical study reports. Read More
Researchers approaching the FDA with new drug development tools, such as potential biomarkers or innovative trial designs, now have a centralized place to bring their ideas for advice, thanks to a new streamlined system that replaces the old fragmented process. Read More
Clinical studies evaluating the safety and tolerability of vaginal microbicide gels to prevent HIV infections should use a scoring system to measure the presence and severity of rash, swelling, immune response and damage to local tissue, FDA final guidance says. Read More
German regulators have published a list of 80 generic medicines whose approvals were yanked after EU authorities expressed concerns with contract research organization GVK Biosciences. Read More